Data on MS ‘vaccine’ Xemys released

[MSUK]

PJSC Pharmsynthez, a pharmaceutical company based in Russia, has announced completed follow-up findings and data analysis from a Phase 2a proof-of-concept clinical trial of its therapeutic vaccine Xemys for the treatment of multiple sclerosis (MS)...Read more - http://www.ms-uk.org/MSnews

[David1949]

No control group? Without that the results are meaningless. People with RRMS have remissions frequently without any treatment.

[DrGeoff]

The absence of a control group is not a good reason to criticize a Phase IIA clinical trial, since the purpose of a IIA trial is to determine the appropriate dosage.
However, the story itself is interesting (and contains ample grounds for criticism).
We have a story put out by a UK organization who seem to do nothing but put out news on MS
They provide a link to an online MS newsletter.
This provides a link to another online news distributor (owned by NASDAQ as it happens)
They offer a press release which just happens to feature two listed companies.
Do you get the feeling that this is second-hand marketing rather than first-hand science?

Going back to the original story (where there is more detail) we find this wonderful statement:

Statistically significant increases in the number of Gadolinium-enhancing lesions were apparent only within the small group of patients who experienced relapse.

In simple terms, they only found evidence of disease progression in the subjects who had disease progression. Wow! Surprise!
And there was significant evidence of disease preogression
One might also criticize the use of steadily increasing doses a a way of finding the optimum dose. when it can really tell you at what point the side effects start to occur.
Geoff

[CureOrBust]

Going back to the original story (where there is more detail) we find this wonderful statement:

Statistically significant increases in the number of Gadolinium-enhancing lesions were apparent only within the small group of patients who experienced relapse.

In simple terms, they only found evidence of disease progression in the subjects who had disease progression. Wow! Surprise!
And there was significant evidence of disease progression
One might also criticize the use of steadily increasing doses a a way of finding the optimum dose. when it can really tell you at what point the side effects start to occur.

The quote you took actually only makes any sense when read with the preceeding sentences

... seven patients (37%) had no evidence of disease activity as measured by NEDA (No Evidence of Disease) scores, and 16 patients (85%) were free of relapse. Only three patients experienced relapses during the trial.

So, the nonsensical sentence you focused on only related to 3 patients; 15%. Yes I agree it was poorly written, but do not throw out the baby with the bath water. However, I can't remember why now, but there was something else that took my interest away from their results when I read the study details. I think I followed it further to the actual study paper (ie not the "media" coverage, where science takes a back seat)